AIRCAST recallZ-1985-2019 · Djo, LLC · initiated Jan 17, 2019
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Djo, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
FDA root cause category: Environmental control
What the company is doing
On January 18, 2019 a Urgent: Medical Device Recall letter was sent via email to customers. The letter ask all customers to send the notification to all customers who have purchased or were issued the affected product. In addition, the letter request that the customer complete the "Return Response" form by February 15, 2019. If you have any additional questions, please contact the firm at 1-800-321-9549.
Recall details
- Recall number
- Z-1985-2019
- Status
- Open, Classified
- Initiated by the company
- Jan 17, 2019
- Recalling firm
- Djo, LLC
- Quantity
- 9 units
- Product code
- JOW
- FDA submissions
- K964238
- Distribution
- Distributed domestically, Oklahoma
Product description
Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.
Code information (models, lots, serial numbers)
Lot # 418003 UDI: (01)00888912302418
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AIRCAST 3011-PLDjo, LLC · SLEEVE, LIMB, COMPRESSIBLE1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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